Risks and benefits of generic antiepileptic drugs.

ABSTRACT

INTRODUCTION: In most therapeutic areas, prescribing generic drugs seems to lower costs without sacrificing efficacy. The use of generic drugs for treating epilepsy may, however, be more controversial. MATERIALS AND METHODS: A systematic review of the literature on generic antiepileptic drugs has been carried out based primarily on a bibliographical search in the Medline database. RESULTS: Published studies are usually of a descriptive nature and are sometimes based on generic drugs that were approved in times when regulatory agency requirements were not as strict as they are now. Experts claim that a change in pharmaceutical formulations could cause seizure recurrence in cases that had been successfully controlled in the past, with severe effects on patients. Meanwhile, several health organizations have provided inconsistent recommendations on the use of generic antiepileptic drugs. CONCLUSION: In order to obtain scientific evidence on the potential risks and benefits of interchanging branded and generic antiepileptic drugs, high methodological comparative studies are necessary. These studies could bring consensus about the role of generic drugs for treating epilepsy.